Insmed has gained FDA approval for its new lung disease medicine, Brinsupri, to treat a chronic condition called bronchiectasis. This approval makes Brinsupri the first drug to target this condition not caused by cystic fibrosis and is part of a new class of drugs known as DPP-1 inhibitors.
Bronchiectasis results in dilated airways, chronic cough, and frequent respiratory infections. The FDA’s approval enables broad adoption of Brinsupri, with few restrictions on its use. Analysts predict up to $6 billion in annual sales for the drug.
Insmed’s market valuation has increased to over $25 billion due to the expected sales from Brinsupri, alongside its other approved drug Arikayce and pipeline candidates in lung disease and Duchenne muscular dystrophy. The company plans to charge $88,000 per year for Brinsupri at list price, with a net price estimated 25-35% lower after rebates.
The FDA’s approval is seen as a positive development, with analysts noting that the drug’s safety cautions are manageable limitations. This clearance comes after Insmed signed deals with Expedition Therapeutics and Fosun Pharma for DPP-1 inhibitors, further expanding its market presence.
Source: https://www.biopharmadive.com/news/insmed-fda-approval-brinsupri-brensocatib-bronchiectasis/757476